Florida Senate - 2015 SB 784
By Senator Gaetz
1-00079B-15 2015784__
1 A bill to be entitled
2 An act relating to health care; providing that this
3 act shall be known as the “Right Medicine, Right Time
4 Act”; creating s. 402.90, F.S.; creating the Clinical
5 Practices Review Commission; housing the commission,
6 for administrative purposes, within the Division of
7 Medical Quality Assurance of the Department of Health;
8 specifying the composition of, qualifications for
9 appointment to, and standards imposed on commission
10 members; designating the members as public officers;
11 requiring the executive director to submit to the
12 Commission on Ethics a list of certain people subject
13 to public disclosure requirements; providing penalties
14 for failure to comply with such standards; specifying
15 the duties and responsibilities of the commission;
16 amending s. 409.967, F.S.; requiring a managed care
17 plan that establishes a prescribed drug formulary or
18 preferred drug list to provide a broad range of
19 therapeutic options to the patient; requiring a
20 managed care plan to comply with specified procedures;
21 creating s. 627.6051, F.S.; requiring sufficient
22 clinical evidence to support a proposed coverage
23 limitation at the point of service; defining the term
24 “sufficient clinical evidence”; requiring the
25 commission to determine whether sufficient clinical
26 evidence exists and the Office of Insurance Regulation
27 to approve coverage limitations if the commission
28 determines that such evidence exists; providing for
29 the liability of a health insurer and its chief
30 medical officer for injuries and damages resulting
31 from restricted access to services if the insurer has
32 imposed coverage limitations without the approval of
33 the office; requiring insurers to establish reserves
34 to pay for such damages; amending ss. 627.642 and
35 627.6699, F.S.; requiring an outline of coverage and
36 certain plans offered by a small employer carrier to
37 include summary statements identifying specific
38 prescription drugs and procedures that are subject to
39 specified restrictions and limitations; requiring
40 insurers and small employer carriers to post the
41 summaries on the Internet; amending s. 627.651, F.S.;
42 conforming a cross-reference; amending s. 627.662,
43 F.S.; specifying that specified provisions relating to
44 coverage limitations on prescription drugs and
45 diagnostic or therapeutic procedures apply to group
46 health insurance, blanket health insurance, and
47 franchise health insurance; amending s. 641.31, F.S.;
48 requiring a health maintenance contract summary
49 statement to include a statement of any limitations on
50 benefits, the identification of specific prescription
51 drugs, and certain procedures that are subject to
52 specified restrictions and limitations; requiring a
53 health maintenance organization to post the summaries
54 on the Internet; prohibiting a health maintenance
55 organization from establishing certain procedures and
56 requirements that restrict access to covered services;
57 exempting limitations that are supported by sufficient
58 clinical evidence; requiring the commission to
59 evaluate the sufficiency of the evidence and the
60 Office of Insurance Regulation to approve coverage
61 limitations on the basis of the commission’s
62 evaluation; providing an effective date.
63
64 Be It Enacted by the Legislature of the State of Florida:
65
66 Section 1. This act shall be known as the “Right Medicine,
67 Right Time Act.”
68 Section 2. Section 402.90, Florida Statutes, is created to
69 read:
70 402.90 Clinical Practices Review Commission.—There is
71 created the Clinical Practices Review Commission, which is a
72 commission as defined in s. 20.03.
73 (1) The commission shall be housed for administrative
74 purposes in the Division of Medical Quality Assurance of the
75 Department of Health.
76 (2) The commission shall consist of seven members
77 appointed, subject to confirmation by the Senate, as follows:
78 (a) Five physicians, one appointed by the Governor, two
79 appointed by the President of the Senate, and two appointed by
80 the Speaker of the House of Representatives, who are currently
81 practicing medicine in this state and have clinical expertise,
82 as evidenced by the following:
83 1. A doctoral degree in medicine or osteopathic medicine
84 from an accredited school;
85 2. An active and clear license issued by this state or
86 another state;
87 3. Board certification in one or more medical specialties;
88 and
89 4. At least 15 years of clinical experience.
90 (b) One individual, appointed by the Governor, with a
91 doctorate in either pharmacology or pharmacy and at least 10
92 years of experience in research or clinical practice with
93 applicable postlicensure credentials.
94 (c) One member, appointed by the Governor, with expertise
95 in the analysis of clinical research, evidenced by a doctoral
96 degree in biostatistics or a related field and at least 10 years
97 of experience in clinical research.
98 (3) A commission member may not currently be an officer,
99 director, owner, operator, employee, or consultant of any entity
100 subject to regulation by the commission. The executive director,
101 senior managers, and members of the commission are subject to
102 part III of chapter 112, including, but not limited to, the Code
103 of Ethics for Public Officers and Employees and the public
104 disclosure and reporting of financial interests pursuant to s.
105 112.3145. For purposes of applying part III of chapter 112 to
106 the activities of the executive director, senior managers, and
107 members of the commission, such persons shall be considered
108 public officers or employees and the commission shall be
109 considered their agency.
110 (a) Notwithstanding s. 112.3143(2), a commission member may
111 not vote on any measure that would inure to his or her special
112 private gain or loss; that he or she knows would inure to the
113 special private gain or loss of any principal by whom he or she
114 is retained, or to the parent organization or subsidiary of a
115 corporate principal by which he or she is retained, other than
116 an agency as defined in s. 112.312; or that he or she knows
117 would inure to the special private gain or loss of a relative or
118 business associate of the public officer. A commission member
119 who is prohibited from voting for such reasons shall publicly
120 state to the assembly, before such a vote is taken, the nature
121 of his or her interest in the matter from which he or she is
122 abstaining from voting and, within 15 days after the vote,
123 disclose the nature of his or her interest as a public record in
124 a memorandum filed with the person responsible for recording the
125 minutes of the meeting, who shall incorporate the memorandum in
126 the minutes.
127 (b) Senior managers and commission members shall also file
128 the disclosures required under paragraph (a) with the Commission
129 on Ethics. The executive director of the commission or his or
130 her designee shall notify each standing and newly appointed
131 commission member and senior manager of his or her duty to
132 comply with the reporting requirements of part III of chapter
133 112. At least quarterly, the executive director or his or her
134 designee shall submit to the Commission on Ethics a list of
135 names of the senior managers and members of the commission who
136 are subject to the public disclosure requirements under s.
137 112.3145.
138 (c) Notwithstanding s. 112.3148, s. 112.3149, or any other
139 law, an employee or member of the commission may not knowingly
140 accept, directly or indirectly, any gift or expenditure from a
141 person or entity, or an employee or representative of such
142 person or entity, which has a contractual relationship with the
143 commission or which is under consideration for a contract.
144 (d) An employee or member of the commission who fails to
145 comply with this subsection is subject to the penalties provided
146 under ss. 112.317 and 112.3173.
147 (4) The duties and responsibilities of the commission
148 include:
149 (a) Development and implementation of policies and
150 procedures for the review of prior authorization, step therapy,
151 or other protocols that limit, at the point of service, access
152 to covered services, including diagnostic procedures,
153 pharmaceutical services, and other therapeutic interventions.
154 (b) Development of any operational policies and procedures
155 that would facilitate the work of the commission, including the
156 establishment of bylaws, the election of a chair, and other
157 administrative procedures.
158 (c) Determination as to the sufficiency of clinical
159 evidence submitted in support of any proposed coverage
160 limitation.
161 (d) Preparation of reports and recommendations that
162 document the proceedings of the commission and identify
163 necessary resources or legislative action.
164 (5) Subject to appropriations, a commission member may
165 receive compensation and per diem and travel expenses as
166 provided in s. 112.061.
167 Section 3. Paragraph (c) of subsection (2) of section
168 409.967, Florida Statutes, is amended to read:
169 409.967 Managed care plan accountability.—
170 (2) The agency shall establish such contract requirements
171 as are necessary for the operation of the statewide managed care
172 program. In addition to any other provisions the agency may deem
173 necessary, the contract must require:
174 (c) Access.—
175 1. The agency shall establish specific standards for the
176 number, type, and regional distribution of providers in managed
177 care plan networks to ensure access to care for both adults and
178 children. Each plan must maintain a regionwide network of
179 providers in sufficient numbers to meet the access standards for
180 specific medical services for all recipients enrolled in the
181 plan. The exclusive use of mail-order pharmacies may not be
182 sufficient to meet network access standards. Consistent with the
183 standards established by the agency, provider networks may
184 include providers located outside the region. A plan may
185 contract with a new hospital facility before the date the
186 hospital becomes operational if the hospital has commenced
187 construction, will be licensed and operational by January 1,
188 2013, and a final order has issued in any civil or
189 administrative challenge. Each plan shall establish and maintain
190 an accurate and complete electronic database of contracted
191 providers, including information about licensure or
192 registration, locations and hours of operation, specialty
193 credentials and other certifications, specific performance
194 indicators, and such other information as the agency deems
195 necessary. The database must be available online to both the
196 agency and the public and have the capability to compare the
197 availability of providers to network adequacy standards and to
198 accept and display feedback from each provider’s patients. Each
199 plan shall submit quarterly reports to the agency identifying
200 the number of enrollees assigned to each primary care provider.
201 2. A managed care plan that establishes a prescribed drug
202 formulary or preferred drug list shall:
203 a. Provide a broad range of therapeutic options for the
204 treatment of disease states which are consistent with the
205 general needs of an outpatient population. If feasible, the
206 formulary or preferred drug list must include at least two
207 products in each therapeutic class.
208 b.2. Each managed care plan must Publish the any prescribed
209 drug formulary or preferred drug list on the plan’s website in a
210 manner that is accessible to and searchable by enrollees and
211 providers. The plan must update the list within 24 hours after
212 making a change. Each plan must ensure that the prior
213 authorization process for prescribed drugs is readily accessible
214 to health care providers, including posting appropriate contact
215 information on its website and providing timely responses to
216 providers.
217 3. For enrollees Medicaid recipients diagnosed with
218 hemophilia who have been prescribed anti-hemophilic-factor
219 replacement products, the agency shall provide for those
220 products and hemophilia overlay services through the agency’s
221 hemophilia disease management program.
222 4.3. Managed care plans, and their fiscal agents or
223 intermediaries, must accept prior authorization requests for any
224 service electronically.
225 5.4. Managed care plans serving children in the care and
226 custody of the Department of Children and Families shall must
227 maintain complete medical, dental, and behavioral health
228 encounter information and participate in making such information
229 available to the department or the applicable contracted
230 community-based care lead agency for use in providing
231 comprehensive and coordinated case management. The agency and
232 the department shall establish an interagency agreement to
233 provide guidance for the format, confidentiality, recipient,
234 scope, and method of information to be made available and the
235 deadlines for submission of the data. The scope of information
236 available to the department is shall be the data that managed
237 care plans are required to submit to the agency. The agency
238 shall determine the plan’s compliance with standards for access
239 to medical, dental, and behavioral health services; the use of
240 medications; and followup on all medically necessary services
241 recommended as a result of early and periodic screening,
242 diagnosis, and treatment.
243 6. Managed care plans shall comply with the procedures for
244 approval of coverage limitations established pursuant to ss.
245 627.6051 and 641.31(44).
246 Section 4. Section 627.6051, Florida Statutes, is created
247 to read:
248 627.6051 Required approval for certain coverage
249 limitations.—
250 (1) A coverage limitation imposed by the insurer at the
251 point of service must be supported by sufficient clinical
252 evidence proving that the limitation does not inhibit timely
253 diagnosis or effective treatment of the specific illness or
254 condition for the covered patient. The term “sufficient clinical
255 evidence” means:
256 (a) A body of research consisting of well-controlled
257 studies conducted by independent researchers and published in
258 peer reviewed journals or comparable publications which
259 consistently support the treatment protocol or other coverage
260 limitation as a best practice for the specific diagnosis or
261 combination of presenting complaints.
262 (b) Results of a multivariate predictive model which
263 indicate that the probability of achieving desired outcomes is
264 not negatively altered or delayed by adherence to the proposed
265 protocol.
266 (2) The Clinical Practices Review Commission established
267 under s. 402.90 shall determine whether sufficient clinical
268 evidence exists for a proposed coverage limitation imposed by
269 the insurer at the point of service. In each instance in which
270 the commission finds that sufficient clinical evidence exists to
271 support a coverage limitation, the office shall approve the
272 coverage limitation.
273 (3) If an insurer, without the approval of the office,
274 imposes a coverage limitation at the point of service,
275 including, but not limited to, a prior authorization procedure,
276 step therapy requirement, treatment protocol, or other
277 utilization management procedure that restricts access to
278 covered services, the insurer and its chief medical officer
279 shall be liable for any injuries or damages, as defined in s.
280 766.202, and economic damages, as defined in s. 768.81(1)(b),
281 that result from the restricted access to services determined
282 medically necessary by the physician treating the patient. An
283 insurer that imposes such a coverage limitation at the point of
284 service shall establish reserves sufficient to pay for such
285 damages.
286 Section 5. Subsection (2) of section 627.642, Florida
287 Statutes, is amended to read:
288 627.642 Outline of coverage.—
289 (2) The outline of coverage must shall contain:
290 (a) A statement identifying the applicable category of
291 coverage afforded by the policy, based on the minimum basic
292 standards set forth in the rules issued to effect compliance
293 with s. 627.643.
294 (b) A brief description of the principal benefits and
295 coverage provided in the policy.
296 (c) A summary statement of the principal exclusions and
297 limitations or reductions contained in the policy, including,
298 but not limited to, preexisting conditions, probationary
299 periods, elimination periods, deductibles, coinsurance, and any
300 age limitations or reductions.
301 (d) A summary statement identifying specific prescription
302 drugs that are subject to prior authorization, step therapy, or
303 any other coverage limitation and the applicable coverage
304 limitation policy or protocol. The insurer shall post the
305 summary statement at a prominent and readily accessible location
306 on the Internet.
307 (e) A summary statement identifying any specific diagnostic
308 or therapeutic procedures that are subject to prior
309 authorization or other coverage limitations and the applicable
310 coverage limitation policy or protocol. The insurer shall post
311 the summary statement at a prominent and readily accessible
312 location on the Internet.
313 (f)(d) A summary statement of the renewal and cancellation
314 provisions, including any reservation of the insurer of a right
315 to change premiums.
316 (g)(e) A statement that the outline contains a summary only
317 of the details of the policy as issued or of the policy as
318 applied for and that the issued policy should be referred to for
319 the actual contractual governing provisions.
320 (h)(f) When home health care coverage is provided, a
321 statement that such benefits are provided in the policy.
322 Section 6. Subsection (4) of section 627.651, Florida
323 Statutes, is amended to read:
324 627.651 Group contracts and plans of self-insurance must
325 meet group requirements.—
326 (4) This section does not apply to any plan that which is
327 established or maintained by an individual employer in
328 accordance with the Employee Retirement Income Security Act of
329 1974, Pub. L. No. 93-406, or to a multiple-employer welfare
330 arrangement as defined in s. 624.437(1), except that a multiple
331 employer welfare arrangement shall comply with ss. 627.419,
332 627.657, 627.6575, 627.6578, 627.6579, 627.6612, 627.66121,
333 627.66122, 627.6615, 627.6616, and 627.662(8) 627.662(7). This
334 subsection does not allow an authorized insurer to issue a group
335 health insurance policy or certificate which does not comply
336 with this part.
337 Section 7. Present subsections (7) through (14) of section
338 627.662, Florida Statutes, are redesignated as subsections (8)
339 through (15), respectively, and a new subsection (7) is added to
340 that section, to read:
341 627.662 Other provisions applicable.—The following
342 provisions apply to group health insurance, blanket health
343 insurance, and franchise health insurance:
344 (7) Section 627.642(2)(d) and (e), relating to coverage
345 limitations on prescription drugs and diagnostic or therapeutic
346 procedures.
347 Section 8. Paragraph (b) of subsection (12) of section
348 627.6699, Florida Statutes, is amended to read:
349 627.6699 Employee Health Care Access Act.—
350 (12) STANDARD, BASIC, HIGH DEDUCTIBLE, AND LIMITED HEALTH
351 BENEFIT PLANS.—
352 (b)1. Each small employer carrier issuing new health
353 benefit plans shall offer to any small employer, upon request, a
354 standard health benefit plan, a basic health benefit plan, and a
355 high deductible plan that meets the requirements of a health
356 savings account plan as defined by federal law or a health
357 reimbursement arrangement as authorized by the Internal Revenue
358 Service, which that meet the criteria set forth in this section.
359 2. For purposes of this subsection, the terms “standard
360 health benefit plan,” “basic health benefit plan,” and “high
361 deductible plan” mean policies or contracts that a small
362 employer carrier offers to eligible small employers which that
363 contain:
364 a. An exclusion for services that are not medically
365 necessary or that are not covered preventive health services;
366 and
367 b. A procedure for preauthorization or prior authorization
368 by the small employer carrier, or its designees;
369 c. A summary statement identifying specific prescription
370 drugs that are subject to prior authorization, step therapy, or
371 any other coverage limitation and the applicable coverage
372 limitation policy or protocol. The carrier shall post the
373 summary statement in a prominent and readily accessible location
374 on the Internet; and
375 d. A summary statement identifying any specific diagnostic
376 or therapeutic procedures subject to prior authorization or
377 other coverage limitations and the applicable coverage
378 limitation policy or protocol. The carrier shall post the
379 summary statement in a prominent and readily accessible location
380 on the Internet.
381 3. A small employer carrier may include the following
382 managed care provisions in the policy or contract to control
383 costs:
384 a. A preferred provider arrangement or exclusive provider
385 organization or any combination thereof, in which a small
386 employer carrier enters into a written agreement with the
387 provider to provide services at specified levels of
388 reimbursement or to provide reimbursement to specified
389 providers. Any such written agreement between a provider and a
390 small employer carrier must contain a provision under which the
391 parties agree that the insured individual or covered member has
392 no obligation to make payment for any medical service rendered
393 by the provider which is determined not to be medically
394 necessary. A carrier may use preferred provider arrangements or
395 exclusive provider arrangements to the same extent as allowed in
396 group products that are not issued to small employers.
397 b. A procedure for utilization review by the small employer
398 carrier or its designees.
399
400 This subparagraph does not prohibit a small employer carrier
401 from including in its policy or contract additional managed care
402 and cost containment provisions, subject to the approval of the
403 office, which have potential for controlling costs in a manner
404 that does not result in inequitable treatment of insureds or
405 subscribers. The carrier may use such provisions to the same
406 extent as authorized for group products that are not issued to
407 small employers.
408 4. The standard health benefit plan shall include:
409 a. Coverage for inpatient hospitalization;
410 b. Coverage for outpatient services;
411 c. Coverage for newborn children pursuant to s. 627.6575;
412 d. Coverage for child care supervision services pursuant to
413 s. 627.6579;
414 e. Coverage for adopted children upon placement in the
415 residence pursuant to s. 627.6578;
416 f. Coverage for mammograms pursuant to s. 627.6613;
417 g. Coverage for children with disabilities handicapped
418 children pursuant to s. 627.6615;
419 h. Emergency or urgent care out of the geographic service
420 area; and
421 i. Coverage for services provided by a hospice licensed
422 under s. 400.602 in cases where such coverage would be the most
423 appropriate and the most cost-effective method for treating a
424 covered illness.
425 5. The standard health benefit plan and the basic health
426 benefit plan may include a schedule of benefit limitations for
427 specified services and procedures. If the committee develops
428 such a schedule of benefits limitation for the standard health
429 benefit plan or the basic health benefit plan, a small employer
430 carrier offering the plan must offer the employer an option for
431 increasing the benefit schedule amounts by 4 percent annually.
432 6. The basic health benefit plan must shall include all of
433 the benefits specified in subparagraph 4.; however, the basic
434 health benefit plan must shall place additional restrictions on
435 the benefits and utilization and may also impose additional cost
436 containment measures.
437 7. Sections 627.419(2), (3), and (4), 627.6574, 627.6612,
438 627.66121, 627.66122, 627.6616, 627.6618, 627.668, and 627.66911
439 apply to the standard health benefit plan and to the basic
440 health benefit plan. However, notwithstanding such said
441 provisions, the plans may specify limits on the number of
442 authorized treatments, if such limits are reasonable and do not
443 discriminate against any type of provider.
444 8. The high-deductible high deductible plan associated with
445 a health savings account or a health reimbursement arrangement
446 must shall include all the benefits specified in subparagraph 4.
447 9. Each small employer carrier that provides for inpatient
448 and outpatient services by allopathic hospitals may provide as
449 an option of the insured similar inpatient and outpatient
450 services by hospitals accredited by the American Osteopathic
451 Association if when such services are available and the
452 osteopathic hospital agrees to provide the service.
453 Section 9. Subsection (4) of section 641.31, Florida
454 Statutes, is amended and subsection (44) is added to that
455 section, to read:
456 641.31 Health maintenance contracts.—
457 (4) Each Every health maintenance contract, certificate, or
458 member handbook must shall clearly state all of the services to
459 which a subscriber is entitled under the contract and must
460 include a clear and understandable statement of any limitations
461 on the benefits, services, or kinds of services to be provided,
462 including any copayment feature or schedule of benefits required
463 by the contract or by any insurer or entity that which is
464 underwriting any of the services offered by the health
465 maintenance organization. The contract, certificate, or member
466 handbook must shall also state where and in what manner the
467 comprehensive health care services may be obtained. The health
468 maintenance organization shall prominently post the statement
469 regarding limitations on benefits, services, or kinds of
470 services provided on its website in a readily accessible
471 location on the Internet. The statement must include, but need
472 not be limited to:
473 (a) The identification of specific prescription drugs that
474 are subject to prior authorization, step therapy, or any other
475 coverage limitation and the applicable coverage limitation
476 policy or protocol.
477 (b) The identification of any specific diagnostic or
478 therapeutic procedures that are subject to prior authorization
479 or other coverage limitations and the applicable coverage
480 limitation policy or protocol.
481 (44) Health maintenance organizations and prepaid health
482 plans are prohibited from establishing prior authorization
483 procedures, step therapy requirements, treatment protocols, or
484 other utilization management procedures that restrict access to
485 covered services unless expressly authorized to do so under this
486 subsection. A coverage limitation imposed by a health
487 maintenance organization or prepaid health plan at the point of
488 service must be supported by sufficient clinical evidence, as
489 defined in s. 627.6051, which demonstrates that the limitation
490 does not inhibit timely diagnosis or optimal treatment of the
491 specific illness or condition for the covered patient.
492 Section 10. This act shall take effect October 1, 2015.